Summary
Overview
Work History
Education
Skills
Websites
Patents
Researchpublications
Awards
Timeline
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Farah Shahjin

Summary

Broadly trained, with 7+ years of hands-on research experience in Cellular and Molecular Biology, including industry experience in Analytical Development and Quality Control in Cell Therapy (CT) and Immunology. Experienced in the method development/qualification; plan, design, perform, analyze, interpret and report results from the studies with minimal supervision and to support IND application. Hands-on experience with multicolor flow cytometry, primary hematopoietic cell isolation and cell-based functional assays in Immunotherapy. Flexible and adaptable; Able to manage multiple projects, prioritize work and meet tight deadlines, collaborate in fast-paced multidisciplinary teams, with changing priorities. Strong interpersonal skills to foster an open and collaborative environment.

Overview

13
13
years of professional experience

Work History

Scientist-Bioanalytics

CMC Analytical Development/Quality Control Cell Therapy, Sanofi
USA
10.2022 - 06.2024
  • Drove Analytical Quality by Design (AQbD)-based analytical target profiling (ATP); independently plan, design, execute, analyze and troubleshoot fit-for-purpose experiments
  • Supported qualification of analytical methods used for the release (potency, identity) and stability testing, forced degradation assays
  • Experienced with cell line and primary cell culture; cell isolation/dissociation, passaging, maintenance of diverse cell line/primary human or animal cells, including but not limited to cells - PBMCs, macrophages, natural killer, T-cells, neurons, microglia, immortalized cells lines; cell counting, growth monitoring, media optimization, cryopreservation, controlled thaw; cell marker identification and characterization
  • Established, optimized, and executed industry-standard in vitro cell-based assays, including multicolor flow cytometry and spectroscopic plate-based cytotoxicity experiments (proliferation, viability, T-/B/NK-cell biomarker characterization, fratricide, cytokine assays for immunophenotypic and functional characterization)
  • Assisted in method transfer to collaborating testing labs and ensuring their robustness and reproducibility
  • Executed cGMP compliant QC testing (release and stability-indicating analytical methods)
  • Performed/Contributed to method bridging studies and comparability studies
  • Experienced in NK-cell culture and maintenance, method optimization, bio-storage and thawing
  • High attention to detail and demonstrated track record of consistently meeting deadlines in a dynamic, fast-paced environment
  • Capable of anticipating and recognizing potential issues within experimental designs and effectively identify and communicate alternatives
  • Able to communicate clearly in writing and orally; excellent record keeping abilities to document
  • Motivated to find solutions and drive to results
  • Supported clinical phase programs (Phase I/II), Stability programs and QC document review and quality event management
  • Have working knowledge of CMC, GLP, GMP regulations and ICH (Q2, Q14)/quality guidelines related to analytical development, qualification, instrument maintenance, QC testing, audit compliance
  • Supported management to resolve out-of-specifications (OOS), deviations and other laboratory investigations
  • Authored/reviewed technical documentation (method development reports and SOPs) to support method transfer to third party and internal QC laboratories; provided technical support for third-party testing laboratories
  • Demonstrated ability to handle multiple projects in a fast-paced environment; self-driven, creative, with a strong team-oriented mentality
  • Collaborated with AD SMEs and the QC team to generate and approve protocols, reports, other technical documents required for the qualification and transfer of analytical methods
  • Collaborated cross-functionally with R&D, Cell Therapy Process Development, and GMP Manufacturing teams for product understanding, to participate in various aspects of method development, transfer, characterization, comparability, and investigation
  • Trained junior laboratory scientists on GLP/GMP practices and nurtured scientific development
  • Team training for new instrument operation.

Ph.D. Candidate

Dept. of Pharmacology and Experimental Neuroscience, UNMC
USA
08.2017 - 07.2022
  • Demonstrated independent project designing and in-depth knowledge in Immunology and novel drug delivery platforms
  • Hands on ability to plan, execute, and troubleshoot wet lab experiments independently; data processing, effectively communicate key results in individual and group settings, author and review/ revise technical documents; with minimal supervision
  • Lead innovation of biomaterial/polymer-based drug-delivery platforms for inactivated SARS-CoV-2 viral antigen delivery; microparticle synthesis, microscopic, spectroscopic and thermos-analytical characterization, ELISA and multi-color flow-cytometry based-immunological (characterization of T-cell and B-cells subsets, intracellular cytokine staining, innate immune cells) and high throughput toxicological assessments
  • Performed in vitro cellular and molecular studies on (i) Neuronal primary cells/ iPSC derived NSCs to explore the physiological and pathological influences of exosomes (ii) Brain-derived extracellular vesicle microRNA/protein signatures using western blotting, qPCR, immunocytochemistry, immunofluorescence, biophysical characterization by NTA, DLS, functional characterization by plate-based spectroscopic assays in models of substance abuse
  • Experienced with diverse cell line/primary cell; including but not limited to neuronal/microglial cell-culture; isolation and culture of neurons, microglia, PBMC, primary immune cells; immortalized cell lines
  • Designed, executed and analyzed in vivo experiments including proof of concept studies; demonstrated expertise in animal handling; dosing (IV, IP, SC, IM), blood/organ collection, dissection and neuronal isolation/culturing, and tissue sectioning, blood profiling
  • Experienced with DNA/RNA/protein handling, isolation, quantitation, and downstream molecular assays
  • SME for Flow Cytometry, ELISA, Microscopic techniques (SEM, TEM, Confocal)
  • Trained and executed viral research under BSL-3 facilities; experienced with viral infection studies
  • Proven verbal and written communication skills, as evidenced by publications, patents, fellowships, and grants; scientific communications in conferences
  • Developed regulatory acumen in protocol (IBC/IACUC) writing
  • Maintain high quality experimental records within ELN
  • Lab management, reagent order, inventory, audit preparedness
  • Excellent organizational skill and project progress accountability
  • Collaborated cross-functionally worked with external parties, including academic collaborators to gain technical and research skills in biophysical characterization (of LNPs and vesicles), anti-retroviral drug substance pre-formulation, and pharmacokinetic studies
  • Mentored junior Ph.D
  • Candidates, lab technicians and summer interns on project relevant techniques and lab safety protocols.

Teaching Faculty

Dept. of Pharmacy, East West University
Bangladesh
01.2013 - 07.2017
  • Teaching subject matters related to Pharmacology, Cell Biology, Toxicology, Pharmaceutical Technology; student counseling and conflict resolution.

Portfolio Manager

Dept. of Strategic Brand Management, Beximco Pharmaceuticals Ltd
Bangladesh
02.2011 - 09.2011
  • Promotional planning, material development, sales representative training for commercial drug product promotion as per local drug regulatory authority guidelines.

Education

Doctor of Philosophy - Biomedical Sciences

University of Nebraska Medical Center (UNMC), NE, USA
01.2022

Master of Pharmacy (M. Pharm) - Pharmaceutical Sciences

University of Dhaka, Bangladesh
01.2012

Bachelor of Pharmacy (B. Pharm.) - Pharmaceutical Sciences

University of Dhaka, Bangladesh
01.2011

Skills

CMC AD/QC

  • Bioassay method development per ICH guidelines
  • Release/Characterization/ Stability testing per cGMP guidelines
  • Bioanalytical (cGMP) document review and quality compliance
  • Support quality event escalation (Deviation, OOT/OOS root cause analyses)
  • Author/review analytical method protocols and technical documents
  • Cross-functional collaboration and support for Manufacturing, In-Process and Process Development teams

Analytical methods

  • Meso Scale Discovery (MSD)
  • ELISA, ELLA
  • Multi-color Flow Cytometry and panel designing (GMP compliant BDFACs Lyric proficiency)
  • Western blotting, Northern blotting, Dot blotting
  • Spectroscopy; UV/Vis, fluorescent, luminescent, colorimetric
  • Fluorescent in situ hybridization (FISH)
  • Microscopy; confocal, time-lapse, fluorescent, SEM, TEM (animal, macaque and human samples)
  • Genotyping, Gel electrophoresis, BCA assay
  • Drug extraction & High-performance liquid chromatography (HPLC)
  • Nanoparticle tracking analysis (NTA)
  • Dynamic light scattering analysis (DLS)
  • pH measurements

Preclinical, in vivo assays

  • IACUC/IBC protocol writing
  • Rodent breeding, restraint, tagging, and dosing (IV, IP, SC, IM) and blood/organ collection
  • Toxicity profiling with VetScans

Cell biology/Virology

  • Cell culture and maintenance: Mammalian- Primary/Cell lines, including Neurons, Microglia, Macrophages, PBMCs, T-cells, NK-cells, Neural and Mesenchymal stem cells
  • Viral culture; BSL2/3 (HIV-1/SARS-CoV-2) infection/inactivation; Cytopathic effect assay, Plaque assay
  • Aseptic techniques
  • ADCC assays; HiBiT technology
  • Cell viability assays; NC-200, Cell Titer Blue, LDH, CellTiter Glo
  • DNA/RNA isolation, Nanodrop quantitation, cDNA preparation, RT-qPCR
  • Transfection
  • Tissue sectioning; paraffin technique using microtome

Pre-Formulation/ DDS platform development

  • Lipid nanoparticle formulation, biophysical characterization
  • Polymer microparticle production by Single emulsion solvent evaporation

Software/System

  • LIMS (STEEL portal)
  • Electronic Lab Notebook (ELN)
  • Veeva Vault RIM (QualiPSO)
  • BD FACS Diva/BD FACS Lyrics/FlowJo/equivalent'
  • Microsoft Office
  • Adobe Illustrator, ImageJ, ZEN
  • SoftMax Pro, GraphPad Prism

Transferable skills

  • Quick learning of new concepts
  • Industrious with 'can-do' attitude
  • Strong work ethics and reliable
  • Multi-tasking, resilience

Patents

  • Microparticle Compositions and methods use thereof, 18/279,459/UNMC Docket No. 21069 US
  • Multimodal Imaging Nanoprobes, Serial No. 63/433,144, Docket No. 22020P1, Filing Date: 12/16/2022

Researchpublications

  • Multipolymer microsphere delivery of SARS-CoV-2 antigens, Acta Biomaterialia, Shahjin, F., Patel M., Machhi J., Cohen J. C., Nayan M. U., Yeapuri P., Zhang C., Waight E., Hasan M., Abdelmoaty, M. A, Dash P., Zhou Y., Andreu I., Gendelman H. E.
  • Kevadiya B. D., 2022
  • Development of a Porous Layer-by-Layer Microsphere with Branched Aliphatic Hydrocarbon Porogens, Nanomedicine: Nanotechnology, Biology and Medicine, Shahjin, F, Patel M., Hasan M., Cohen J. C., Islam I., Ashaduzzaman M., Nayan M. U., Subramaniam M., Zhou Y., Andreu I, Gendelman H. E.
  • Mesenchymal stem cell-derived extracellular vesicles: challenges in clinical applications, Frontiers in cell and developmental biology, Gowen, A.
  • Shahjin, F.
  • Chand, S., Odegaard, K. E., Yelamanchili, S. V., 2020
  • Brain-derived extracellular vesicle microRNA signatures associated with in utero and postnatal oxycodone exposure, Shahjin, F.
  • Guda, R. S.
  • Schaal, V. L., Odegaard, K., Clark, A., Gowen, A., Xiao, P., Lisco, S. J., Pendyala, G., Yelamanchili, S. V., 2019
  • Extracellular vesicles as drug delivery vehicles to the central nervous system, Journal of neuroimmune pharmacology, Shahjin, F., Chand, S., Yelamanchili, S. V., 2019

Awards

  • Research Innovation Awards New Invention in 2022 UNeMed at UNMC. Investigation of the effect of different pore forming agents on polymer-based microparticles.
  • Research Innovation Awards New Invention in 2021 UNeMed at UNMC. Development of a layer-by-layer microparticle for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine.
  • UNMC Assistantship/Fellowship, 2021-2022
  • Neuroscience T32 grant, 2020-2021
  • Outstanding Poster Presentation award in 2019 and 2021, Dept. of Pharmacology and Experimental Neuroscience)
  • Early Career Investigator Travel Award (ECITA); 25th annual meeting of the Society on Neuroimmune Pharmacology (SNIP), 2019.

Timeline

Scientist-Bioanalytics

CMC Analytical Development/Quality Control Cell Therapy, Sanofi
10.2022 - 06.2024

Ph.D. Candidate

Dept. of Pharmacology and Experimental Neuroscience, UNMC
08.2017 - 07.2022

Teaching Faculty

Dept. of Pharmacy, East West University
01.2013 - 07.2017

Portfolio Manager

Dept. of Strategic Brand Management, Beximco Pharmaceuticals Ltd
02.2011 - 09.2011

Doctor of Philosophy - Biomedical Sciences

University of Nebraska Medical Center (UNMC), NE, USA

Master of Pharmacy (M. Pharm) - Pharmaceutical Sciences

University of Dhaka, Bangladesh

Bachelor of Pharmacy (B. Pharm.) - Pharmaceutical Sciences

University of Dhaka, Bangladesh

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Farah Shahjin